Flow regulating device in the heart

ABSTRACT

A blood flow regulator for creating a shunt in the heart, comprising; a proximal element having a general disc-shape, defined by a braid of one or more wires extending about a central aperture of the proximal element; a distal element having a general disc-shape, defined by a braid of one or more wires extending about a central aperture of the distal element; and a third element defining a neck section intermediate the proximal and distal elements and forming a cavity having a diameter no greater than a diameter of each of the distal and proximal elements, wherein said distal element comprises at least one loop of a wire extending radially outwardly from a center of the distal element and returning towards said center of said distal element.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/508,473, filed Mar. 2, 2017, entitled A Flow Regulating Device In TheHeart, which is the National Phase of and claims priority toInternational Patent Application No. PCT/EP2015/070659 InternationalFiling Date Sep. 9, 2015, entitled A Flow Regulating Device In TheHeart; which claims benefit of U.S. Provisional Application Ser. No.62/047,843 filed Sep. 9, 2014 entitled A Flow Regulating Device In TheHeart; and U.S. Provisional Application Ser. No. 62/077,680 filed Nov.10, 2014 entitled A Flow Regulating Device In The Heart; all of whichare incorporated herein by reference in their entireties

FIELD OF THE INVENTION

This disclosure pertains in general to the field of medical implants.More particularly, the disclosure relates to a device suitable forimplantation in the atrial septum in the heart of a mammal. The deviceproviding a precise dimension for an opening in the septum, with apredetermined diameter, where the device remains open for apredetermined period of time, and serving to control flow rate acrossthe septum.

BACKGROUND OF THE INVENTION

In a healthy heart which is composed of four chambers, atria collect theblood from body and the lungs, and the ventricles pump the blood to thelungs and the body. The oxygenated blood which is pumped by the leftventricles carries oxygen to the body. Deoxygenated blood is returned tothe right heart via veins and pumped to the lungs via pulmonary arteryoriginated from the right heart. The oxygenated blood in the lungs flowsinto the left atrium via pulmonary veins and then to the left ventriclewhere it is pumped to the body. Right and left chambers of the heart areseparated by a wall to avoid the mixture of oxygenated and deoxygenatedblood. Congenital opening between right and left atria of the heart iscalled as ASD (atrial septal defect). In the presence of an ASD,oxygenated blood in the left atrium flows into the right atrium, and theamount of the blood to be pumped by the right atria increases. In time,this would lead to overload, hypertension in the pulmonary arteries(pulmonary hypertension) and heart failure, decreasing life expectancy.Moreover, the emboli passing through this hole may reach to the brainleading to strokes. If the blood flowing through the left atrium to theright atrium is above a certain amount, ASD must be occluded. Otherwise,irreversible damage may occur in the pulmonary arteries.

In the fetal heart, there is a hole (foramen ovale) between the atria,and this hole is partially covered by a membrane. This hole between themembrane allows the blood to pass from right to left atria, and it isvital for the baby. Following the birth, the membrane closes the hole,and in few months the hole is completely occluded in most cases.

The Atrial Flow Regulator (AFR) or the blood flow regulating device, asreferred to as below, is intended to create a hole (small ASD) betweenthe two collecting chambers in the heart (right and Left Atria), i.e.opposite to the purpose of an occluder. This will allow flow of bloodfrom a chamber that is stiff and under high pressure to a chamber thatis less stiff and under lesser pressure. By creating such a hole,symptoms resulting from back flow of blood into the areas filling thatchamber could be prevented. For example, if the pressure in the leftatria (LA) is high then the back pressure would be into the lungs fromwhich the oxygenated blood is draining into the LA. This causes thepatient to be breathless and give symptoms like coughing and aninability to lie flat or climb stairs. Creating a hole in the atrialseptum will decompress the LA into a less-stiff and low pressure RightAtrium (RA). This would help the patient to be free of such symptoms.Similarly, if the Right Atrium (RA) is under high pressure or becomesstiff from a failing Right Ventricle (RV), the chamber can bedecompressed by a hole created in the atrial septum. This will reducesymptoms from high pressure in the veins draining into the RA like liverveins, kidney veins, veins from the intestine, etc.

When such a hole is created, it should be calibrated so as to controlthe amount of pressure drop and amount of blood flowing through thehole. When blood flows from the RA to LA, the patients may become bluerbut will have better blood flow into the vital organs. If the blood flowis from LA to the RA then there is no problem with saturations but theremay be a slight reduction in blood flow into the organs during more thanmoderate exercise which otherwise would have been not possible in thosepatients.

Although rare, there are some risks during the transcatheter procedure.While attempting to make a hole to implant the AFR, laceration orbleeding may occur in vessels which may require surgical invention orblood transfusion. Infection is another risk following the procedure,which may require antibiotic treatment. Very rarely stroke andaccordingly long term function loss may occur. Allergic reactions orloss of renal functions may develop due to contrast material. Creating ahole may also predispose the patient to paradoxic embolism and stroke ifthe blood flows from right to left.

Urgent surgical intervention may be needed due to inappropriate locationof the AFR device or premature release of the device form the catheter.The device can be dislocated after being released and it may harm theadjacent heart valves. This situation may require operation. Rarely, thedevice may not be implantable or clots can form around the device,leading to embolism.

Sivaprakasam M, Kiesewetter C, Veldtman G R, Salmon A P, Vettukattil J.published an article “New technique for fenestration of the interatrialseptum” j intery cardiol In 2006 August 19(4):334-6. This was created byimprovised use of a stent not intended for this use. However, it isimportant to ensure that the defect created in the heart is a precisediameter to a calibrated size to allow appropriate amount of blood flow,just enough to maintain the necessary cardiac output without causingother complications like severe decrease in oxygenation, devicedislodgement, decrease in the size of hole in the device etc. It isequally important that such devices are precisely positioned to avoiddamage or dysfunction of healthy heart tissues or structures.

Prior devices for creating a shunt or an opening in the heart have amiddle section, which can be called the conjoined ring, which iscircular and provides most of the support to the right and leftdisc-shaped end sections in order to keep its circular shape andcalibrated diameter, and to keep its shape memory. Such a device can beplaced between two cardiac chambers. To allow pressure reduction betweenthe two cardiac chambers, a manual hole is made by splaying the wires ofthe device. A problem with previous devices is lack of stability andthereby difficulties in attaining a well-defined calibrated opening.Moreover, with conventional devices, due to the hole being in the ringthat latches on to the wall or septum (partition between the twochambers), the hole may get covered in the process ofendothelialisation, i.e. the natural process of the body to cover anyforeign material. A further problem with prior art device is thedisruption of the endothelialization process, which can cause formationof embolies travelling in the blood stream.

Thus with prior art device there is a challenge to achieve sufficientstability, a sufficiently well-defined shunt, and reduced risk offormation of embolies.

Thus, it would be advantageous to provide an improved blood flowregulating device with improved stability, allowing for improvedsupport, and the ability to retain the calibrated size, and improvedproperties with respect to endothelialization, as well as a method ofmanufacturing such device.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present disclosure preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing an AFR device or blood flow regulating deviceaccording to the appended patent claims.

According to a first aspect of the disclosure a blood flow regulator forcreating a shunt in the heart is disclosed comprising a proximal elementhaving a general disc-shape, defined by a braid of one or more wiresextending about a central aperture of the proximal element, a distalelement having a general disc-shape, defined by a braid of one or morewires extending about a central aperture of the distal element, and athird element defining a neck section intermediate the proximal anddistal elements and forming a cavity having a diameter no greater than adiameter of each of the distal and proximal elements. The distal elementcomprises at least one loop of a wire extending radially outwardly froma center of the distal element and returning towards said center of thedistal element.

According to a second aspect of the disclosure a method of manufacturinga blood flow regulator is disclosed comprising braiding a tubular braidof wires, where opposite ends of each wire are arranged at a proximalportion of the tubular braid, and loops of the wires are arranged at adistal end of the tubular braiding. The method comprising forming adistal disc of the distal end of the tubular braiding, forming aproximal disk of the proximal end of the tubular braiding, forming acentral aperture in each of the distal and proximal discs such that saidapertures are joined by a central channel of the tubular braiding,extending between said discs, and fixating the opposite ends of wire ina connecting element located at the proximal disk with an off-setdistance from a central axis extending through the channel.

Some embodiments of the disclosure provide for retaining the size of theshunt, and thereby the desired blood flow.

Some embodiments of the disclosure provide for improved anchoring of thedevice, while maintaining a high flexibility to adapt to variousgeometries.

Some embodiments of the disclosure provide for an improved stability ofthe device.

Some embodiments of the disclosure provide for reduced risk of formationof emboli.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe disclosure are capable of will be apparent and elucidated from thefollowing description of embodiments of the present disclosure,reference being made to the accompanying drawings, in which;

FIGS. 1 a-b illustrate a blood flow regulator according to embodimentsof the invention in a top-down view of the distal disc and in side view,respectively;

FIGS. 2 a-b illustrate a blood flow regulator according to embodimentsof the invention in a top-down view of the distal disc and in side view,respectively;

FIGS. 3 a-b illustrate a blood flow regulator according to embodimentsof the invention in a top-down view of the proximal disc and distaldisc, respectively;

FIGS. 4 a-b illustrate a blood flow regulator according to embodimentsof the invention in a cross-sectional side view and in a perspectiveview of the proximal disc, respectively;

FIG. 4 c illustrates a blood flow regulator according to an embodimentof the invention in a schematic cross-sectional side view of the outlineof the braiding;

FIGS. 4 d-e illustrate a blood flow regulator according to an embodimentof the invention in further perspective views, where FIG. 4 d is across-sectional view;

FIGS. 5 a-c illustrate a blood flow regulator according to embodimentsof the invention in a top-down plan view, a cross-sectional side view,and in a perspective side view, respectively;

FIGS. 6 a-c illustrate a blood flow regulator according to embodimentsof the invention in a top-down plan view, a cross-sectional side view,and in a perspective side view, respectively;

FIGS. 7 a-c illustrate a blood flow regulator according to embodimentsof the invention in a top-down plan view, a cross-sectional side view,and in a perspective side view, respectively;

FIGS. 8 a-c illustrate a blood flow regulator according to embodimentsof the invention in a top-down plan view, a cross-sectional side view,and in a perspective side view, respectively;

FIG. 9 illustrate a catheter used for implantation of a blood flowregulator according to embodiments of the invention; and

FIG. 10 is a flow-chart of a method of manufacturing a blood flowregulator according to embodiments of the invention.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the disclosure now will be described withreference to the accompanying drawings. This disclosure may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the disclosure to those skilled in the art.The terminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the disclosure. In the drawings, like numbers refer to like elements

The following description focuses on embodiments of the presentdisclosure applicable to blood regulating devices for septal defects.However, it will be appreciated that the disclosure is not limited tothis application but may be applied to many other medical implantsincluding for example stents, vascular devices, and various otherdevices that can be provided with a well-defined shunt such as a Patentforamen ovale (PFO) device, a PDA device, or a ventricular septal defect(VSD) device.

FIG. 1 a is a blood flow regulator 100 for creating a shunt in theheart, comprising a proximal element 101 having a general disc-shape,defined by a braid of one or more wires extending about a centralaperture 103 of the proximal element. The blood flow regulator furthercomprise a distal element 102 having a general disc-shape, defined by abraid of one or more wires extending about a central aperture 104 of thedistal element, and a third element 105 defining a neck sectionintermediate the proximal and distal elements and forming a cavity 106,i.e. a trough hole or channel extending through the proximal element,the distal element and the third element. The proximal and distalelements are placed on either side of the septum, with the third element105 situated within the septum. The diameter of the cavity 106 is notgreater than the diameter of each of the distal and proximal elements101, 102. The distal element 102 comprises at least one loop 107 of awire extending radially outwardly from a center 108 of the distalelement 102 and returning towards said center 108 of the distal element102. I.e. the braiding of the distal element 102 comprises wires thatextend radially outward, i.e. radiates out to a perimeter, from thecenter axis 108, and then returning towards the center axis 108, therebyforming a loop wire 107. FIG. 1 b illustrates only schematically anexample of such loop wire 107. FIG. 1 a illustrates the blood flowregulator device in a cross-sectional side view. This advantageouslyremoves the need of having to collect wire ends at the distal element ofthe blood flow regulator 100. A problem with prior art devices is thatany element at the distal end collecting the wire ends, such as aconnector, weld, or hub, presents a discontinuity in the braiding whichwill create less than optimal conditions for the endothelializationprocess, and even result in formation of embolies. Distal connectorswill in some instances even protrude from the distal element and therebyfurther disrupt the endothelialization process. Thus, the wire loops 107of the braiding at the distal element 102 will provide for a smooth,even, and continuous distal surface that allows for optimal conditionsfor formation of endothelia. In some embodiments of the invention, allof the wires forming the distal element 102 are loop wires 107, thus thedistal element 102 is free from wire ends, that will provide for thesmooth, even, and continuous distal surface with the advantagesdescribed previously. FIG. 2 a shows a top-down view of the distalelement or disc 102 of blood flow regulator device 100, showing the loopwires 107 having their apex at the peripheral region of the distal disc102. In this embodiment, also all of the wires forming the braiding ofthe distal element are loop wires 107, whereby the distal element isfree from wire ends.

The proximal element 101, the distal element 102, and the third element105 may be formed of the same braiding of one or more wires. Thus theblood flow regulator device 100 may be formed from the same single pieceof braiding, which is illustrated in e.g. FIGS. 2 a-b, and 3 a-b . Thisprovides for a flexible device that adapts well to the anatomy, afterexpanding out of the delivery catheter, while at the same time providinggood fixation at the implanted site and the necessary support forkeeping an open channel, and further, less manufacturing steps. Thedevice 100 can flatten, fold, or collapse inside of delivery catheterand the respective elements of the device recover their original shapeafter removal from catheter.

The device 100 may comprise one or more radiopaque markers (not shown)in order to identify the device 100 during the procedure. The radiopaquemarker can be applied to any part of the device. The marker may beapplied at the periphery of the aperture 103 or 104, so that the channel106 can be clearly localized. It may be desired to access the opening106 with a catheter.

The proximal element may comprise a connecting element 109 for adelivery device, wherein ends of the one or more wires are fixed to theconnecting element. The distal element 102 comprises returning loops 107of the one or more wires whereby opposite ends of the one or more wiresforming the distal element 102 are fixed to the connecting element 109.Thus, the ends of the wires forming the distal element 102 are fixatedto the connecting element 109 at the proximal end 101. FIG. 2 b , whichis a side-view, and FIG. 3 a , which is a view of the proximal end 101,illustrates how the ends of the wires are fixated to the connectingelement 109, and there is no other connecting element present, or wireend that is not terminating in the proximal connecting element 109. Thedistal element 102 can therefore be formed of the wire loops 107 andpresent a flat and smooth surface with the advantages discussed above.Having a smooth, continuous distal surface, which requires fixation ofall wire ends to a single proximal connecting element 109, whilesimultaneously having the connecting element 109 arranged with anoff-set distance 119, allowing for the a through channel 106 across thedevice 100, is advantageously provided and possible due to having thewires at the proximal end 101 looped around the central aperture 103 asillustrated in FIG. 3 a.

The braiding at a perimeter 110 of the distal element 102 may be foldedradially inwards to form a double layer 111 braid around the perimeter110 of the distal element 102, which is illustrated schematically inFIG. 4 c . Like the proximal element 101, the distal element 102 maythus have a double layer of braiding around a peripheral portionthereof. The fold 111 may extend with a length radially inwards towardsthe center axis 108 as desired. The perimeter 110 of the distal disc canthus be provided with a more even circular shape, e.g. comparing FIG. 2a which is not folded with FIG. 3 b which has the folded braiding, whichcan be advantageous with respect to the handling of the device and alsothe behavior of the device when implanted, as the fold 111 can furtherincrease the structural integrity of the device 100.

The blood flow regulator 100 may further comprise a membrane 112arranged around the cavity or channel 106, which is illustrated in FIG.4 a . The membrane 112 can prevent ingrowth of tissue in the cavity 106,thus providing for maintaining the desired flow for long-term use. Themembrane can be provided on the outside or the inside of the thirdelement 105. The membrane can be applied by coating a polymer fiber onthe third element 105. The polymer fiber can be applied by a spincoating process, where the device 100 can be rotated while spraying thepolymer fiber onto the device 100.

The distal element 102 may further comprise of a membrane 113 thatpromotes endothelialization. In addition, or alternatively, the proximalelement 101 may further comprises of membrane 114 that promotesendothelialization. FIG. 4 a illustrates how the membranes, 112, 113,114, may be arranged on the blood flow regulator 100, but the membranecoverage in the device 100 may be varied as desired for the application.FIGS. 6 b and 8 a also illustrate a membrane arranged at the proximalelement, but may also be positioned at the distal element.

The distal element 102 may comprise non-braided filaments 115 formingpetal-shaped loops 116, which is illustrated in FIGS. 6 a -c.

The flow control device illustrated in FIGS. 6 a-c is thus partlybraided and has comparatively less amount of metallic structure than thepreviously described examples in FIGS. 1-4 . Having less metal mayfacilitate the incorporation the device in the body since the tissueovergrowth can be faster. The non-braided filaments may have a differentrigidity or flexibility which may be advantageous in some applications.The strength of disc-shaped region of distal element 102 does not affectthe strength of the proximal element 101.

The device 100 in FIGS. 6 a-c is designed to create a shunt betweenvessels and heart chambers while minimizing metallic structure andfacilitating calibration of a diagnostic system. The filament bodystructure 115 of the distal element 101 may be formed of one or morenitinol filaments, or any other metal alloy that is biocompatible, andbeing able to heat set in the desired shape. It may be advantageous tohave at least three filaments 115, which can be equally spaced apart toachieve the desired stability of the device 100.

The retention force of the distal element 102 can be adjusted byselecting the number of filaments 115.

The distal element 102 may be formed from a single filament wire or itcan be formed from a plurality of filament wires.

A desired filament body structure may employ, for example, 3, 4, 5, 126, 7, 8, 9, 10, or 12 pieces of filaments as desired depending on theuse of the device. All these filaments may have a regular or irregularfilament body structure, e.g. forming forming a petal shape asmentioned, where each filament 115 extend from the axial center 108 of ageometric plane, and each filaments joining each other in a radiallyinward location, e.g. by welding. The filament body structure may beobtained using techniques such as pinching sutures or wires together orhooking sutures or wires together.

The filaments 115 may be of equal gauge or of different gauge (wiresize).

The distal element 102 and the proximal element 101 may be formedseparately and combined prior to implantation. The third element 105,may also be formed separately.

It is possible to manufacture the proximal and distal elements withcompletely different properties independently.

It is also possible that the proximal element 101 is formed fromnon-braided filament wires 115, which can assume a petal-shaped proximalportion.

In a method, the different parts can be joined using techniques such aswelding, pinching, clamping or hooking a plurality of wires together.

It is also possible that a braided device 100, having a braided proximal101 and distal 102 element and a third neck portion 105 is combined withnon-braided filament wires 115.

Further, the proximal and distal elements 101, 102, may be braided withdifferent wire thicknesses, which would allow e.g. different expansionforces of the proximal and distal elements 101, 102, such as when havinga non-braided distal element 102.

The proximal and distal elements 101, 102, are expandable, and theproximal element may thus have a lower expansion strength than thedistal element.

The third element 105 may be resilient such that it is deformable to anon-circular shape in a septum of the heart, such as to an at leastpartly oval shape or any irregular shape. In general the device 100 haselastic properties making it suitable both systolic and diastolic motionof the septum, in particular the atrial septum. The third element 105may be flexible to allow movement of the proximal and distal elements101, 102, relative to each other, in the plane of the disc-shapedelements, i.e. a parallel sliding motion. This is advantageous in someirregular-shaped anatomies. Further the third element 105 may movementin the axial direction, along the centre axis 108, which allows for acertain adaptation to the geometry of the anatomy also in thisdirection.

The third element 105 may have an at least partly oval cross-section inthe relaxed, unstrained, heat-set shape. This may be advantageous insome anatomies, and the device can more easily adapt to the anatomywithout producing unnecessary strain or dislocation. The cavity 106 maythus also be formed as desired, e.g. having the oval cross-section. Theproximal and distal elements 101, 102, may also have varying shapes,such as oval or other irregular shapes as may be advantageous forvarying anatomies, and not only disc-shaped. The oval or irregularshapes of the mentioned elements are formed in the heat-settingprocedure with respectively shaped molds, such that the shapes can bemaintained.

The connecting element 109 may be joined to the proximal portion 101 viaa flexing element 117 formed from the one or more wires being fixated tothe connecting element, as illustrated in e.g. FIGS. 2 b and 4 c . Thisallows for a flexibility between the connecting element 109 and theproximal and distal portions 101, 102 of the device 100, which can beadvantageous during the implantation procedure, e.g. in narrow anatomieswhere the angle between the delivery device and the blood flowregulating device 100 needs to be increased at the implantation stage,and the pivoting motion provided by the connecting element itself maynot be sufficient.

The connecting element 109 may be formed by a weld having an at leastpartly spherical shape, as illustrated in e.g. FIG. 2 b . This allowsfor the mentioned pivoting motion by grasping the connecting elementwith a delivery device having a holder with the corresponding sphericalsurface.

The distal element 102 may comprise an at least partly concave shape 118being concave in a direction towards the proximal element 101, which isillustrated in e.g. FIGS. 1 a and 2 b . This facilitates a flushapposition of the distal element 102 against the tissue, and alsoimproved fixation, since the concave surface forms an angled rim at theperiphery of the distal disc that may flex against the tissue, therebycreating a bias force against the tissue in the axial direction 108. Theproximal element may also have a concave shape towards the distalelement 102, as illustrated in FIG. 1 a . FIG. 4 a illustrates the casewhere the distal element 102 and the proximal element 101 are generallyparallel to each other. It may however be possible to have varyingangles between these elements.

The central apertures 103, 104, may be arranged concentrically in theproximal and distal elements 101, 102, respectively, as illustrated ine.g. FIG. 3 b . Such symmetry may be advantageous with respect tostructural stability of the device 100 and may provide for a more secureanchoring of the device 100 at the implanted site since the discportions of the proximal and distal ends has a uniform overlap with thetissue.

The membrane 113 of the distal element, and/or the membrane 114 of theproximal element may be formed of a thin, flexible material and compriseat least one of; a partially biodegradable material; a filament; anelastic polymeric material; or one or more natural fabrics such as silkor wool can be used.

In one embodiment, the membrane 113, 114, is formed of a wovenpolyester. The membrane 113, 114, may be made of a dense material.Membranes 113, 114, can also be made, at least partly, by abiodegradable material, which also facilitate thrombosis.

The membrane 113, 114, may comprise an elastic polymeric materialselected from a group including nylon, polyester, polypropylene,polytetrafluoroethylene, and expanded polytetrafluoroethylene.

In one embodiment, at least one of the distal element 102 or theproximal element 101 includes a coating, preferably a cell proliferationcoating. The use of a cell proliferation coating enhances the adhesionand proliferation of endothelial cells onto surfaces. The use of similarcoatings may further provide faster endothelization.

Table 1 and FIG. 4 a show possible dimensions of the outer diameter D2of the distal and/or proximal elements, as well as the diameter D1 ofthe cavity 106, and the closest distance (h) between the proximal anddistal elements 101, 102. The dimensions are given for respectivepuncture size. In FIGS. 4 a, 4 d, 4 e , the proximal and distal discshave similar or same diameter, but the diameters of these discs may bedifferent and varied as desired for the application. E.g. FIG. 4 billustrates a larger proximal disc. Alternatively, the distal disc maybe larger than the proximal disc.

TABLE 1 Introducing Puncture D1 D2 h System Size Size [mm] [mm] [mm]ODS* D ≤ 4 4 17 2  8F  5 < D ≤ 6 6 19 2 10F 6.5 < D ≤ 8  8 22 2 12F 7.5< D ≤ 10 10 24 2 14F D ≤ 4 4 17 5  8F  5 < D ≤ 6 6 19 5 10F 6.5 < D ≤ 8 8 22 5 12F 7.5 < D ≤ 10 10 24 5 14F D ≤ 4 4 17 10  8F  5 < D ≤ 6 6 19 1010F 6.5 < D ≤ 8  8 22 10 12F 7.5 < D ≤ 10 10 24 10 14F

FIGS. 5 a-c, 6 a-c, 7 a-c, and 8 a-c are other illustrations of theblood flow regulating device 100 described above. Diameters D1 and D2are indicated in FIG. 5 a . D1 may be varied to provide the desired flowin the shunt, while D2 is varied to provide sufficient anchoring of thedevice at the septum. Further dimensions of the device 100 are discussedwith reference to FIGS. 6 a-c, 7 a-c, and 8 a-c . For example, withreference to FIG. 6 a , dimension D9 is an angular distance betweencrests of two adjacent nitinol filaments (loops) 115, which are formedto create the distal unit 102 of the flow control device 100. DimensionD10 is intended as a reference to nitinol wire diameter, which may varyaccording to device size. Turning to FIG. 5 b , dimension D4 is thediameter of a connecting element 109 used to connect the flow controldevice to a pusher cable of a catheter used for device implantation.Dimension D5 is a distance between a proximal element surface 101′ ofthe proximal element 101 and the connecting element 109. As illustratedin FIG. 6 b , for example, dimension D6 is the thickness of the membrane114 on the proximal element 101 of the flow control device 100. Thethickness of the membrane 113 on the distal element 102 is notindicated, but the thickness of the both membranes can be equal. Turningto FIG. 7 b , dimension D8 is the thickness of the frame between thecavity diameter D1 and the waist diameter of the third element 105. Asillustrated in FIG. 5 a , dimension D3 is the distance between the outertangent of the flow control device diameter and the center of theconnecting element 109. FIGS. 7 a-c illustrate a flow control device 100having a cavity 106 with a larger diameter than e.g. the device 100illustrated in FIGS. 5 a-c and 6 a-c , thus used for providing a largeropening. FIGS. 8 a-c illustrate a flow control device 100, which is usedto create a hole in a body with a longer connecting neck, i.e. having alonger dimension (h), for different applications such as posteriordescending artery (PDA) stenting. Generally, the two discs on the twosides of the device provide maximum support with a clamping force andwith a very limited distance between the disc, providing for improvedanchoring and stabilization of the device after implantation, andmaintaining the calibrated size of the channel.

FIG. 10 illustrates a method 200 of manufacturing a blood flow regulator100. The method comprises braiding 201 a tubular braid of wires, whereopposite ends of each wire are arranged at a proximal portion of thetubular braid, and loops of the wires are arranged at a distal end ofthe tubular braiding. The method comprises forming 202 a distal disc 102of the distal end of the tubular braiding, forming 203 a proximal disk101 of the proximal end of the tubular braiding. The method 200 furthercomprises forming 204 a central aperture 103, 104, in each of the distaland proximal discs such that the apertures are joined by a centralchannel 106 of the tubular braiding, extending between the discs, andfixating 205 the opposite ends of wire in a connecting element 109located at the proximal disk with an off-set distance 119 from a centralaxis 108 extending through the channel. The off-set distance 119 isillustrated in FIG. 4 a , and may be varied as desired for providing theoptimal location of the connecting element 109.

The method 200 may further comprise folding 206 the braiding at aperimeter 110 of the distal element 102 radially inwards to form adouble layered braid 111 around the perimeter 110 of the distal element102.

The various flow control device 100 of the present disclosure are usedin medical procedures to provide a shunt in the body, such as in anatrial septum. The medical procedure in question may also comprises offollowing steps. Positioning the flow control device with a restrainingcatheter. Positioning a pushing cable into the restraining catheteradjacent to the device. Inserting the restraining catheter, the pushingcable, and the device into the body at a transdermal site. Positioningthe distal end of the restraining catheter at the target site and thedevice inside the body opening created by a previous interventionalmethod such as septostomy.

Pushing the device through the restraining catheter with the pushingcable until the device has been released, so that distal element of thedevice is positioned on an inside of a rupture. Removing the pushingcable and the retraining catheter, so that distal part of the distalunit of the device is positioned on an inside of a rupture to be shapedby the device. FIG. 9 shows a lateral view of a catheter suitable foruse in the above described medical procedure for closure of a hole in abody. The catheter is used to deliver the flow control device, alsoreferred to as the blood flow regulating device 100, to the desiredlocation and perform a precise implantation. In one exemplary use, adelivery sheath is placed in the punctured hole in the arterial septumwith the aid of a guide wire. The pusher cable with a plastic torquecontrol is used to advance the flow control device to the desiredlocation and to deploy the flow control device when it is advanced tothe right location.

The present disclosure has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the disclosure.Different method steps than those described above, may be providedwithin the scope of the disclosure. The different features and steps ofthe disclosure may be combined in other combinations than thosedescribed. The scope of the disclosure is only limited by the appendedpatent claims. More generally, those skilled in the art will readilyappreciate that all parameters, dimensions, materials, andconfigurations described herein are meant to be exemplary and that theactual parameters, dimensions, materials, and/or configurations willdepend upon the specific application or applications for which theteachings of the present disclosure is/are used.

What is claimed is:
 1. A method of shunting a heart comprising:providing a braided flow control device having a disc-shaped proximalelement, a disc-shaped distal element, a neck section therebetween andno more than one connecting element, said one connecting elementdisposed on said proximal element; delivering said braided flow controldevice through a catheter to a rupture in a wall of a heart chamber;urging force against said one connecting element to deploy said braidedflow control device until said disc-shaped distal element and saiddisc-shaped proximal element are positioned on either side of saidrupture in said wall of a heart chamber allowing said braided flowcontrol device to thereby control blood flow across said rupture of saidheart.
 2. A method according to claim 1, wherein urging force againstsaid one connecting element comprises urging force against a pluralityof wires that make up said braided flow control device, said pluralityof wires terminating at said connecting element.
 3. A method accordingto claim 1, wherein urging force against said one connecting elementcomprises urging force against a spherically shaped connecting element.4. A method according to claim 1, further comprising puncturing a holein said wall of a heart chamber to create said rupture.
 5. A methodaccording to claim 1, wherein said wall of a heart chamber is an atrialseptum.
 6. A method according to claim 1, wherein urging force againstsaid one connecting element comprises pushing against a cable in contactwith said one connecting element.
 7. A method of affecting blood flow ina heart comprising: providing a flow control device having a proximalelement, a distal element, a neck section therebetween and no more thanone connecting element, said one connecting element disposed on saidproximal element; delivering said flow control device through a catheterto a rupture in a wall of a heart chamber; urging force against said oneconnecting element to deploy said flow control device until said distalelement and said proximal element are positioned on either side of saidrupture in said wall of a heart chamber allowing said braided flowcontrol device to thereby control blood flow across said rupture of saidheart.
 8. A method according to claim 7, wherein said distal andproximal elements are disc-shaped.
 9. A method according to claim 7,wherein said flow control device is comprised of a plurality of wiresthat originate and terminate at said one connecting element.
 10. Amethod according to claim 7, wherein urging force against said oneconnecting element comprises urging force against a plurality of wiresthat make up said flow control device, said plurality of wiresoriginating and terminating at said connecting element.
 11. A methodaccording to claim 7, wherein urging force against said one connectingelement comprises urging force against a spherically shaped connectingelement.
 12. A method according to claim 7, further comprisingpuncturing a hole in said wall of a heart chamber to create saidrupture.
 13. A method according to claim 7, wherein said wall of a heartchamber is an atrial septum.
 14. A method according to claim 7, whereinurging force against said one connecting element comprises pushingagainst a cable in contact with said one connecting element.